MAUDE brand profile

SPECTRANETICS LEAD LOCKING DEVICE

MAUDE brand safety profile

Key facts

Brand name SPECTRANETICS LEAD LOCKING DEVICE

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 100–999 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Iatrogenic Source, Device Embedded In Tissue or Plaque, Cardiac Perforation, Pericardial Effusion, Low Blood Pressure/ Hypotension, Break, Mechanical Problem Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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